China NMPA Product Recall - Craniofacial surgical instruments (trade name: SYNTHES) and craniofacial bone plates (trade name: Synthes)

Synthes GmbH, distributed by Johnson & Johnson (Shanghai) Medical Devices Co., Ltd., initiated a voluntary recall of craniofacial surgical instruments and bone plates. This action, reported to the National Medical Products Administration (NMPA), stemmed from an error in labeling: the packaging inserts of the crimping tools incorrectly stated the products were "MR Safe." This claim contradicts the ASTM F2503 standard, which explicitly prohibits marking metal devices as "MR Safe." The manufacturer acknowledged that the products' safety and compatibility in an MRI environment, including potential heating, movement, or image artifacts, had not been assessed. Consequently, their MRI safety remains unknown, posing a potential risk of injury to patients with implanted devices during an MRI scan. Although these medical devices hold CFDA Import Medical Device Registration Certificates, a crucial aspect of this recall is that none of the affected products were imported into or sold within China. Therefore, Johnson & Johnson Medical Companies' required actions for the Chinese market were limited to officially reporting the issue to the State Food and Drug Administration. No further assessment reports, implementation plans, or summary reports were necessary from the company for the Chinese market. However, provincial regulatory bodies were instructed to enhance their supervision and management of similar products.